Final results of the ReoPro readministration registry.

Authors

Jean-Pierre Dery
Gregory A Braden
A Michael Lincoff
Dean J Kereiakes
Kevin Browne
Thomas Little
Barry S George
David C Sane
Douglas B Cines
Mark B Effron
Mary Ann Mascelli
Mary Ann Langrall
Lakshmi Damaraju
Elliot S Barnathan
James E Tcheng

Publication/Presentation Date

4-15-2004

Abstract

Because of its potential for antigenicity, theoretical concerns related to readministration of abciximab have been raised. We conducted the ReoPro Readministration Registry to assess the efficacy and safety of abciximab readministration. A total of 1,342 patients who underwent percutaneous coronary intervention and who received abciximab for at least a second time were recruited. Safety end points were hypersensitivity reactions, major bleeding, and thrombocytopenia (TCP). Human antichimeric antibody (HACA) titers were determined before and after readministration. Procedural success was 98% and was not influenced by the number of courses of abciximab or the presence of HACA. There were no cases of anaphylaxis. There were 5 minor allergic reactions, none of which required termination of the infusion. Clinically significant bleeding occurred in 31 patients (2.3%), including 1 (0.07%) with intracranial hemorrhage. TCP (10(9)/L) developed in 5% of patients; profound TCP (10(9)/L) occurred in 2%. In patients who received abciximab within 1 month of a previous treatment (n = 115), the risk of developing TCP and profound TCP was 16.5% and 12.2%, respectively. Having a positive HACA before readministration was not correlated with adverse clinical outcomes or bleeding, but was associated with TCP (14.1% vs 4.4%, p = 0.002) and profound TCP (5.6% vs 1.6%, p = 0.036). Readministration of abciximab can be accomplished without severe allergic responses and with a bleeding and efficacy profile similar to first-time administration. However, the rate of severe and profound TCP is increased relative to first-time administration, particularly when the time between treatments ispresent.

Volume

93

Issue

8

First Page

979

Last Page

984

ISSN

0002-9149

Published In/Presented At

Dery, J. P., Braden, G. A., Lincoff, A. M., Kereiakes, D. J., Browne, K., Little, T., George, B. S., Sane, D. C., Cines, D. B., Effron, M. B., Mascelli, M. A., Langrall, M. A., Damaraju, L., Barnathan, E. S., Tcheng, J. E., & ReoPro Readministration Registry Investigators (2004). Final results of the ReoPro readministration registry. The American journal of cardiology, 93(8), 979–984. https://doi.org/10.1016/j.amjcard.2003.12.051

Disciplines

Medicine and Health Sciences

PubMedID

15081439

Department(s)

Department of Medicine

Document Type

Article